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Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers

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ClinicalTrials.gov Identifier: NCT03680560
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Unum Therapeutics Inc.

Brief Summary:
This is a Phase 1, open-label, multi-center study to assess safety and determine the recommended phase 2 dose (RP2D) of ACTR T cell product (ACTR707 or ACTR087) in combination with trastuzumab, following lymphodepleting chemotherapy in subjects with HER2-positive advanced malignancies.

Condition or disease Intervention/treatment Phase
Solid Tumor HER-2 Protein Overexpression Biological: ACTR T Cell Product Drug: Trastuzumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of an Autologous ACTR T Cell Product in Combination With Trastuzumab, a Monoclonal Antibody, in Subjects With HER2-Positive Advanced Malignancies
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: ACTR T cell product in combination with trastuzumab Biological: ACTR T Cell Product
Autologous Antibody-Coupled T Cell Receptor (ACTR) T Cell Product (ACTR707 or ACTR087)

Drug: Trastuzumab
monoclonal antibody targeting HER2




Primary Outcome Measures :
  1. Safety and tolerability of ACTR T cell product with trastuzumab as assessed by committee review of dose limiting toxicities (DLTs), incidence and severity of adverse events (AEs) and clinically significant abnormalities of laboratory values [ Time Frame: 42 days ]
  2. Determination of recommended phase 2 dose (RP2D) regimen [ Time Frame: 42 days ]
    Review of DLTs, maximum tolerated dose (MTD), incidence and severity of AEs and clinically significant abnormalities of laboratory values


Secondary Outcome Measures :
  1. Anti-tumor activity as measured by overall response rate (ORR) per iRECIST [ Time Frame: 52 weeks ]
  2. Anti-tumor activity as measured best overall response (BOR) [ Time Frame: 52 weeks ]
  3. Anti-tumor activity as measured by duration of response (DOR) [ Time Frame: 52 weeks ]
  4. Anti-tumor activity as measured by progression-free survival (PFS) [ Time Frame: 52 weeks ]
  5. Anti-tumor activity as measured by overall survival (OS) [ Time Frame: 52 weeks ]
  6. Assessment of persistence of ACTR as measured by flow cytometry [ Time Frame: 52 weeks ]
  7. Assessment of persistence of ACTR as measured by quantitative polymerase chain reaction (qPCR) [ Time Frame: 52 weeks ]
  8. Assessment of ACTR phenotype and function as measured by flow cytometry [ Time Frame: 52 weeks ]
  9. Assessment of induction of inflammatory markers and cytokines/chemokines after ACTR T cell product administration [ Time Frame: 52 weeks ]
    Levels of inflammatory markers, cytokines/chemokines in blood

  10. Trastuzumab pharmacokinetics (PK) [ Time Frame: 52 weeks ]
    trastuzumab serum concentration, Area Under the Curve (AUC), trough levels



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent obtained prior to study procedures
  • Histologically-confirmed Her2 positive advanced solid tumor malignancy with documented disease progression during or immediately following the immediate prior therapy, or within 6 months of completing adjuvant therapy for subjects with breast cancer
  • Subjects must have previously received adequate standard therapy for treatment of their malignancy

    • For those with metastatic breast cancer, must have received HER2-directed therapy including trastuzumab, pertuzumab and ado-trastuzumab in any breast cancer disease setting
    • For those with advanced gastric cancer, adequate prior treatment with HER2-directed chemotherapy is required
  • At least 1 measurable lesion by iRECIST
  • Able to provide fresh tumor biopsy or archived block specimen taken since time of most recent anti-HER2 mAb-directed therapy
  • ECOG of 0 or 1
  • Life expectancy ≥ 6 months
  • LVEF ≥ 50% by MUGA or ECHO
  • Absolute neutrophil (ANC) count ≥ 1500/ µL
  • Platelet count ≥ 100,000/µL
  • Hemoglobin ≥ 9g/dL
  • Estimated GFR >30mL/min/1.73m2

Exclusion Criteria:

  • glioblastoma multiforme or other primary CNS tumors are excluded
  • clinically significant cardiac disease
  • clinically significant active infection
  • clinical history, prior diagnosis, or overt evidence of autoimmune disease
  • current use of more than 5mg/day of prednisone (or an equivalent glucocorticoid)
  • Prior treatment as follows:

    • prior cumulative doxorubicin dose greater than or equal to 300 mg/m^2 or equivalent
    • chemotherapy within 2 weeks of enrollment
    • external beam radiation within 2 weeks of enrollment (28 days if CNS-directed therapy)
    • any monoclonal antibody (mAb) or other protein therapeutic containing Fc-domains within 4 weeks of enrollment
    • pertuzumab within 4 months of enrollment
    • Experimental agents within 3 half-lives or 28 days prior to enrollment, whichever is shorter
    • allogeneic hematopoietic stem cell transplant (HSCT)
    • prior infusion of a genetically modified therapy
  • Pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680560


Contacts
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Contact: Susan Griffin 617-276-5843 sue.griffin@unumrx.com
Contact: Glen Weiss, MD glen.weiss@unumrx.com

Locations
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United States, Connecticut
Yale Smilow Cancer Hospital Recruiting
New Haven, Connecticut, United States, 06511
Contact: Alexandra Dormal       alexandra.dormal@yale.edu   
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Robert Wesolowski, MD    614-293-5066    robert.wesolowski@osumc.edu   
Contact: Kristina Susi    614-685-8618    kristina.susi@osumc.edu   
United States, Tennessee
Sarah Cannon Research Institute/Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
Contact: Renee Thompson    615-341-7810    renee.thompson@sarahcannon.com   
United States, Texas
Baylor Scott & White Medical Center Recruiting
Dallas, Texas, United States, 75201
Contact: Carlos Becerra, Dr.    214-818-8472      
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Ecaterina Dumbrava, MD       eelleana@mdanderson.org   
Contact: Jeane Painter, PhD    713-792-3537    jmgovan@mdanderson.org   
Sponsors and Collaborators
Unum Therapeutics Inc.

Additional Information:
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Responsible Party: Unum Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03680560     History of Changes
Other Study ID Numbers: ATTCK-34-01
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Unum Therapeutics Inc.:
ACTR
ACTR087
ACTR707
HER2
T cell
T cell product
adoptive T cells
gene therapy
breast cancer
gastric cancer
gastro esophageal cancer
immunotherapy
solid tumor
adenoid cystic carcinoma
Additional relevant MeSH terms:
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Trastuzumab
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents